Drug Approval | July 24, 2024
Zydus receives USFDA’s final approval for Valsartan Tablets
The drug will be manufactured at the group's formulation manufacturing facility in Ahmedabad SEZ - II, India
The drug will be manufactured at the group's formulation manufacturing facility in Ahmedabad SEZ - II, India
Ephedrine Sulfate injection USP, 50 mg/mL is indicated for the treatment of clinically important hypotension
Zydus receives final approval from USFDA for its NDA Zituvimeta, extended-release tablets
Rusan’s API facility in Ankleshwar is GMP approved by other stringent international agencies as well
Doxorubicin Hydrochloride Liposome Injection (RLD Doxil) had estimated annual sales of USD 42 million in the U.S. (IQVIA MAT May 2024)
The inspection closed with five observations which were more of procedural changes with none of these related to data integrity
The facility is a part of Lupin Manufacturing Solutions
Sacubitril and Valsartan combination is used to treat chronic heart failure in adults
Diroximel Fumarate Delayed-Release Capsules is indicated for the treatment of relapsing forms of multiple sclerosis
This product will be manufactured at Lupin’s Pithampur facility in India
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